FDA.report

510(k) K823685

Device
FILE TYPE H (HEDSTROEM) ENDODONTIC
Applicant
UNITED DENTAL MFG., INC.
510(k) number
K823685
Product code
EKS  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-28
Date received
1982-12-07
Regulation
872.4565
Classification name
File, Pulp Canal, Endodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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